Tag: Drug Approvals
FDA Approves Imbruvica for Pediatric Chronic Graft Versus Host Disease
Approval is for chronic disease after failure of one or more lines of systemic therapy
Tabrecta Gains Full FDA Approval for Non-Small Cell Lung Cancer
Drug approved for non-small cell lung cancer with mutation leading to MET exon 14 skipping
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
HER2-low is a new classification for a subset of HER2-negative breast cancer
FDA Approves Skyrizi for Moderately to Severely Active Crohn Disease
Skyrizi is first specific interleukin-23 approved to treat Crohn disease
New Cancer Drugs Approved Faster in U.S. Than Europe
FDA received licensing applications sooner and had shorter review times, compared to the European Medicines Agency
FDA Approves First Pill to Treat Severe Alopecia Areata
Olumiant is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot
Increased Flexibility Seen in Preapproval Evidence for New Drugs
Twenty-eight percent of trials used historical, external, or other control; nearly half used surrogate measure as a primary end point
Use of Extrapolation Common in FDA New Drug Approvals
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
Vijoice Granted First Approval for Treatment of PROS
Real-world data show 27 percent of patients with PIK3CA-related overgrowth spectrum treated with Vijoice had radiological response at 24 weeks
FDA Expands Approval of Jardiance for Patients With Heart Failure
Jardiance received approval to reduce the risk for cardiovascular death and hospitalization for patients with heart failure
